The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.
Participants must be >18 years old at time of diagnosis
Histologically confirmed non-small cell lung cancer
ECOG PS 2
Clinical staging of IIIc or IV disease.
Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis
Patients on immunosuppressive medication, including steroids (if doses exceed equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to start of treatment are acceptable.
Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator.
The patient must not be on any clinical trials involving other experimental therapies during study treatment
Parallel
Pembrolizumab
DrugPembrolizumab 200 mg
Pemetrexed (Chemotherapy)
Other intervention500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
Nab-paclitaxel (Chemotherapy)
Other intervention100 mg/m2 days 1,8 of 21 day cycle x 4 cycles
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy
Percentage of participants with Complete Response or Partial Response
Determine the proportion of patients who achieve a complete or partial response as their best overall response based on RECIST v1.1 criteria will be evaluated. Patients with nonevaluable or unknown response status will be considered nonresponders.
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